April 2021 FDA Recall Drug by Edge Pharma, Llc
D-0335-2021 - Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility

This Class II drug recall was voluntarily initiated by Edge Pharma, Llc on April 12, 2021 for the product Drug. The FDA reported the reason for recall as defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0335-2021

Reason for Recall
Defective container; syringe content migrating past the seal of the plunger may cause a lack of assurance of sterility
Initiated
04-12-2021
Reported
04-28-2021
Quantity
5850 syringes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87710
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Edge Pharma, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in the US
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-11-2022
Product Description About Product Description
Full technical description of the product.
Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, For Topical Ophthalmic Use (DO NOT INJECT) STERILE OPHTHALMIC SOLUTION, PRESERVATIVE FREE, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178

Batch or Lot Expiration Information

Lot# Lot 02-2021-16@4 BUD 5/31/2021